NCT04038320

Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine

Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 868 (actual)
• Sponsor: Right to Care · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The project will evaluate cost and treatment outcomes of a simplified Hepatitis C Virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations in Ukraine.

Detailed description

Affected populations will be screened for HCV and HIV and those HCV positive treated with direct with direct acting anti-HCV agents (DAAs), a fixed-dose combination of sofosbuvir/ledipasvir (SOF/LDV) for 12 weeks with or without weight-based ribavirin. Before and after completion of the treatment course viral load assessments will be undertaken using low-cost laboratory monitoring for comparison to standard HCV viral load measurement. Up 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Response (SVR) will be determined. Safety monitoring will be undertaken at applicable visits for those on Ribavirin and all adverse events will be reported based on Good Clinical Practice (GCP). In addition to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of SVR at 12 weeks after end of treatment ( defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of SVR12. The project will be conducted at 2 treatment sites in Kiev.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Sofosbuvir/ledipasvir (SOF/LDV)	SOF/LDV (400mg/90mg) orally once daily with or without food in the morning and will receive treatment for a duration of 12 weeks. In addition, Ribavirin weight-based (1000 mg for patients \<75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food for Genotype 3 patients.

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-03-30
• Completion: 2019-06-30
• First posted: 2019-07-30
• Last updated: 2019-07-30

Locations

2 sites across 1 country: Ukraine

Regulatory

• FDA-regulated drug study